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FDA Issues Draft Guidance for Regulating Transgenic Animals

Sep 22, 2008

The U.S. Food and Drug Administration last Thursday released for public comment its draft guidance on the regulation of genetically engineered animals, also known as transgenic animals. According to the guidance, FDA plans to consider transgenic animals under the animal drug provisions of the Federal Food, Drug and Cosmetic Act and to evaluate the safety of each new transgenic animal on a case-by-case basis. The comment period will close November 18. FDA news release / FDA draft guidance


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